As of this week, the following products manufactured from expanded cord blood have been granted expedited pathways to FDA approval.
Parent's Guide to Cord Blood Foundation published a review of expanded cord blood products in May 2018.
Date |
Expanded |
Manufacturer |
Indication |
FDA Expedited Path(s) |
20180717 |
Gamida Cell |
HSCT: Hematopoietic |
Breakthrough Therapy |
|
20180806 |
NLA101 |
Nohla Therapeutics |
HSCT engraftment, |
Orphan Drug |
20180823 |
Medipost |
Bronchopulmonary Dysplasia |
Orphan Drug |
|
20190423 |
ExCellThera |
Hematologic |
Regenerative Medicine Advanced Therapy (RMAT) |
|
20190904 |
Magenta |
Inherited Metabolic Disorders |
Regenerative Medicine Advanced Therapy (RMAT) |